Why is off label marketing of a drug prohibited by law?

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asked Feb 28, 2024 225k views

1 Answer

Armaan Sandhu · Answer 1 · 2024-03-05T08:31:12+0000

Off-label marketing of a drug is prohibited by law to ensure safety, avoid potential harm to patients, and promote ethical prescribing practices.

Off-label marketing of a drug is prohibited by law for several reasons:

Firstly, the FDA (Food and Drug Administration) approves drugs for specific indications or medical uses. Companies are only allowed to advertise or promote a drug for the specific approved use. Off-label use refers to using a drug for indications not approved by the FDA.
Secondly, off-label use can pose risks to patients as the drug may not have been tested or proven to be safe and effective for the particular off-label use. This can lead to adverse effects and potential harm to patients.
Lastly, prohibiting off-label marketing helps ensure that drugs are accurately and transparently marketed to healthcare professionals and patients. It promotes ethical and evidence-based prescribing practices, ensuring that patients receive appropriate and approved treatments.